title: Real-time PCR-assay in the delivery suite for determination of group B streptococcal colonization in a setting with risk-based antibiotic prophylaxis.
abstract: OBJECTIVE
  Intrapartum antibiotic prophylaxis (IAP) reduces the incidence of neonatal early onset group B streptococcal infections. The present study investigated if an automated PCR-assay, used bedside by the labor ward personnel was manageable and could decrease the use of IAP in a setting with a risk-based IAP strategy.
  
  
  METHODS
  The study comprises two phases. Phase 1 was a multicenter, randomized, controlled trial. Women with selected risk-factors were allocated either to PCR-IAP (prophylaxis given if positive or indeterminate) or IAP. A vaginal/rectal swab and superficial swabs from the neonate for conventional culture were also obtained. Phase 2 was non-randomized, assessing an improved version of the assay.
  
  
  RESULTS
  Phase 1 included 112 women in the PCR-IAP group and 117 in the IAP group. Excluding indeterminate results, the assay showed a sensitivity of 89% and a specificity of 90%. In 44 % of the PCR assays the result was indeterminate. The use of IAP was lower in the PCR group (53 versus 92%). Phase 2 included 94 women. The proportion of indeterminate results was reduced (15%). The GBS colonization rate was 31%.
  
  
  CONCLUSIONS
  The PCR assay, in the hands of labor ward personnel, can be useful for selection of women to which IAP should be offered.
authors.affiliation: Department of Pediatrics, University Hospital , Umeå , Sweden .
authors.forename: Stellan
authors.initials: S
authors.lastname: Håkansson
authors.forename: Karin
authors.initials: K
authors.lastname: Källén
authors.forename: Maria
authors.initials: M
authors.lastname: Bullarbo
authors.forename: Per-Åke
authors.initials: PÅ
authors.lastname: Holmgren
authors.forename: Katarina
authors.initials: K
authors.lastname: Bremme
authors.forename: Asa
authors.initials: A
authors.lastname: Larsson
authors.forename: Margareta
authors.initials: M
authors.lastname: Norman
authors.forename: Håkan
authors.initials: H
authors.lastname: Norén
authors.forename: Catharina
authors.initials: C
authors.lastname: Ortmark-Wrede
authors.forename: Karin
authors.initials: K
authors.lastname: Pettersson
authors.forename: Sissel
authors.initials: S
authors.lastname: Saltvedt
authors.forename: Birgitta
authors.initials: B
authors.lastname: Sondell
authors.forename: Magdalena
authors.initials: M
authors.lastname: Tokarska
authors.forename: Anna
authors.initials: A
authors.lastname: von Vultee
authors.forename: Bo
authors.initials: B
authors.lastname: Jacobsson
mesh_terms: D019072:Antibiotic Prophylaxis / Q000379:methods*; D004269:DNA, Bacterial / Q000032:analysis*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D018743:Perinatal Care / Q000379:methods*; D011247:Pregnancy; D060888:Real-Time Polymerase Chain Reaction; D018570:Risk Assessment; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013290:Streptococcal Infections / Q000175:diagnosis* / Q000517:prevention & control / Q000635:transmission; D013292:Streptococcus agalactiae / Q000235:genetics / Q000302:isolation & purification*
chemical_list: D004269:DNA, Bacterial